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IPS Effect 20 g 1

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 545017

by Ivoclar Vivadent AG

Identity

Trade Name
IPS Effect 20 g 1 EUDAMED
IPS Classic FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
IPS Classic EUDAMED
IPS Effect 20 g 1 FDA UDI
Model / Reference
545017 EUDAMEDFDA UDI
Description
IPS Effect 20 g 1 FDA UDI

Identifiers

Catalog Number
545017 FDA UDI
Primary DI / UDI-DI
07615208406191 EUDAMEDFDA UDI
Basic UDI-DI
76152082ACERA003EU EUDAMED
FDA Product Code
EIH FDA UDI
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Market of Registration
Liechtenstein EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

IPS Effect 20 g 1 by Ivoclar Vivadent AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ivoclar Vivadent AG
EUDAMED SRN
LI-MF-000000522

Sources (2)

  • EUDAMED 158f366a-a677-46d0-83c7-79ff916cd023 61 fields · synced Oct 6, 2026
  • FDA UDI ea825e28-059d-4355-b1b6-2a51bf539074 34 fields · synced May 30, 2026